Apparatus and method for forming pilot holes in bone and delivering fasteners therein for retaining an implant

ABSTRACT

Apparatus and methods for forming pilot holes in bone and deploying a staple therein for fixing a sheet-like implant to the bone. A pilot hole forming trocar assembly including a trocar and a position retention sleeve can be included. The trocar can be releasably coupled to the position retention sleeve and slide in keyed arrangement within the sleeve when uncoupled. The trocar can include a distal portion having a retractable blade and a pair of pilot hole forming spikes extending distally from the trocar shaft. Once the pilot holes are formed, the position retention sleeve maintains the position relative to the pilot holes while the trocar is removed and a staple delivery device can be inserted in the lumen of the position retention sleeve to deploy a staple in the pilot holes.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application No.61/577,621 filed on Dec. 19, 2011, the disclosure of which isincorporated by reference herein.

The present disclosure is also related to the following commonlyassigned co-pending applications the disclosures of which areincorporated herein by reference: U.S. Provisional Application No.61/577,626 filed on Dec. 19, 2011, Attorney Docket No. 10322-712.100entitled, “FASTENERS AND FASTENER DELIVERY DEVICES FOR AFFIXINGSHEET-LIKE MATERIALS TO BONE OR TISSUE”; U.S. Provisional ApplicationNo. 61/577,632 filed on Dec. 19, 2011, Attorney Docket No. 10322-713.100entitled, “FASTENERS AND FASTENER DELIVERY DEVICES FOR AFFIXINGSHEET-LIKE MATERIALS TO BONE OR TISSUE” and U.S. Provisional ApplicationNo. 61/577,635 filed on Dec. 19, 2011, Attorney Docket No. 10322-714.100entitled, “FASTENERS AND FASTENER DELIVERY DEVICES FOR AFFIXINGSHEET-LIKE MATERIALS TO BONE OR TISSUE.”

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

FIELD

The present invention relates generally to orthopedic medicine andsurgery. More particularly, the present invention relates to methods andapparatus for forming pilot holes in bone for inserting fasteners andfixation of sheet-like materials, such as for treating tendons or liketissue of articulating joints, such as tendons in the rotator cuff ofthe shoulder.

BACKGROUND

The glenohumeral joint of the shoulder is found where the head of thehumerus mates with a shallow depression in the scapula. This shallowdepression is known as the glenoid fossa. Six muscles extend between thehumerus and scapula and actuate the glenohumeral joint. These sixmuscles include the deltoid, the teres major, and the four rotator cuffmuscles. The rotator cuff muscles are a complex of muscles. The musclesof the rotator cuff include the supraspinatus, the infraspinatus, thesubscapularis, and the teres minor. The centering and stabilizing rolesplayed by the rotator cuff muscles are critical to the proper functionof the shoulder. The rotator cuff muscles provide a wide variety ofmoments to rotate the humerus and to oppose unwanted components of thedeltoid and pectoral muscle forces.

The muscles of the rotator cuff arise from the scapula. The distaltendons of the rotator cuff muscles splay out and interdigitate to forma common continuous insertion on the humerus. The supraspinatus musclearises from the supraspinatus fossa of the posterior scapula, passesbeneath the acromion and the acromioclavicular joint, and attaches tothe superior aspect of the greater tuberosity. The mechanics of therotator cuff muscles are complex. The rotator cuff muscles rotate thehumerus with respect to the scapula, compress the humeral head into theglenoid fossa providing a critical stabilizing mechanism to the shoulder(known as concavity compression), and provide muscular balance. Thesupraspinatus and deltoid muscles are equally responsible for producingtorque about the shoulder joint in the functional planes of motion.

The rotator cuff muscles are critical elements of this shoulder musclebalance equation. The human shoulder has no fixed axis. In a specifiedposition, activation of a muscle creates a unique set of rotationalmoments. For example, the anterior deltoid can exert moments in forwardelevation, internal rotation, and cross-body movement. If forwardelevation is to occur without rotation, the cross-body and internalrotation moments of this muscle must be neutralized by other muscles,such as the posterior deltoid and infraspinatus. The timing andmagnitude of these balancing muscle effects must be preciselycoordinated to avoid unwanted directions of humeral motion. Thus thesimplified view of muscles as isolated motors, or as members of forcecouples must give way to an understanding that all shoulder musclesfunction together in a precisely coordinated way—opposing musclescanceling out undesired elements leaving only the net torque necessaryto produce the desired action. Injury to any of these soft tissues cangreatly inhibit ranges and types of motion of the arm.

With its complexity, range of motion and extensive use, a common softtissue injury is damage to the rotator cuff or rotator cuff tendons.Damage to the rotator cuff is a potentially serious medical conditionthat may occur during hyperextension, from an acute traumatic tear orfrom overuse of the joint. With its critical role in abduction,rotational strength and torque production, the most common injuryassociated with the rotator cuff region is a strain or tear involvingthe supraspinatus tendon. A tear at the insertion site of the tendonwith the humerus, may result in the detachment of the tendon from thebone. This detachment may be partial or full, depending upon theseverity of the injury or damage. Additionally, the strain or tear canoccur within the tendon itself. Injuries to the supraspinatus tendon andcurrent modalities for treatment are defined by the type and degree oftear. The first type of tear is a full thickness tear, which as the termindicates is a tear that extends through the thickness of thesupraspinatus tendon regardless of whether it is completely tornlaterally. The second type of tear is a partial thickness tear which isfurther classified based on how much of the thickness is torn, whetherit is greater or less than about 50% of the thickness.

The accepted treatment for a full thickness tear or a partial thicknesstear greater than 50% includes reconnecting the torn tendon via sutures.For the partial thickness tears greater than 50%, the tear is completedto a full thickness tear by cutting the tendon prior to reconnection. Incontrast to the treatment of a full thickness tear or a partialthickness tear of greater than 50%, the current standard treatment for apartial thickness tear less than 50% usually involves physical cessationfrom use of the tendon, i.e., rest. Specific exercises can also beprescribed to strengthen and loosen the shoulder area. In manyinstances, the shoulder does not heal and the partial thickness tear canbe the source of chronic pain and stiffness. Further, the pain andstiffness may cause restricted use of the limb which tends to result infurther degeneration or atrophy in the shoulder.

Surgical intervention may be required for a partial thickness tear ofless than 50%, however, current treatment interventions do not includerepair of the tendon, and rather the surgical procedure is directed toarthroscopic removal of bone to relieve points of impingement or createa larger tunnel between the tendon and bone that is believed to becausing tendon damage. As part of the treatment, degenerated tendon mayalso be removed using a debridement procedure in which tendon materialis ablated. Again, the tendon partial thickness tear is not repaired.Several authors have reported satisfactory early post operative resultsfrom these procedures, but over time recurrent symptoms have been noted.In the event of recurrent symptoms, many times a patient will “live withthe pain”. This may result in less use of the arm and shoulder whichcauses further degeneration of the tendon and may lead to more extensivedamage. A tendon repair would then need to be done in a later procedureif the prescribed treatment for the partial tear was unsuccessful inrelieving pain and stiffness or over time the tear propagated throughinjury or degeneration to a full thickness tear or a partial thicknesstear greater than 50% with attendant pain and debilitation. A subsequentlater procedure would include the more drastic procedure of completingthe tear to full thickness and suturing the ends of the tendon backtogether. This procedure requires extensive rehabilitation, hasrelatively high failure rates and subjects the patient who firstpresented and was treated with a partial thickness tear less than 50% toa second surgical procedure.

As described above, adequate treatments do not currently exist forrepairing a partial thickness tear of less than 50% in the supraspinatustendon. Current procedures attempt to alleviate impingement or make roomfor movement of the tendon to prevent further damage and relievediscomfort but do not repair or strengthen the tendon. Use of the stilldamaged tendon can lead to further damage or injury. Prior damage mayresult in degeneration that requires a second more drastic procedure torepair the tendon. Further, if the prior procedure was only partiallysuccessful in relieving pain and discomfort, a response may be to usethe shoulder less which leads to degeneration and increased likelihoodof further injury along with the need for more drastic surgery. Further,it would be beneficial to be able to treat partial thickness tearsgreater than 50% without cutting the untorn portion of the tendon tocomplete the tear before suturing back together. There is a large needfor surgical techniques and systems to treat partial thickness tears andprevent future tendon damage by strengthening or repairing the nativetendon having the partial thickness tear.

SUMMARY OF THE DISCLOSURE

The present disclosure is generally directed to an arthroscopicapparatus and method to form pilot holes in bone and retain instrumentposition relative to formed pilot holes such that a fastener may bedelivered into the pilot holes for retention therein. The fastener canbe used to fix a sheet-like material or implant to bone in a procedureto place such implant over damaged tendon in an articulating joint, suchas the rotator cuff.

In some embodiments, the apparatus generally includes a pilot holeforming trocar assembly having a position retention sleeve and a trocarslidably disposed therein. The position retention sleeve can have alumen extending therethrough and at least one position retention memberproximate a distal end of the position retention sleeve. The trocar canbe sized for being releasably disposed within the lumen of the positionretention sleeve and can include at least one distally extending spike.When assembled for use, the at least one distally extending spike canextend beyond the distal end of the position retention sleeve to form apilot hole when contacted with bone.

The pilot hole forming trocar can be included in a kit that furtherincludes a staple delivery device. The staple delivery device caninclude a barrel sized for disposition within the lumen of the positionretention sleeve and delivery of a staple from a distal portion thereof.The barrel can be keyed for controlled rotational relationship of thebarrel relative to the position retention sleeve.

In some embodiments, the trocar can include a collar for releasablycoupling the trocar to the position retention sleeve. Further, aproximal knob portion having a surfacing for pounding the at least onespike into bone can be included on the trocar. A retractable blade foraccessing an incision site can also be included on a distal end of thetrocar.

The position retention sleeve can include a plurality of positionretention members. The position retention members can include asemi-cylindrical member defining a longitudinal channel over the lengththereof that is sized to allow the at least one spike of the trocar tobe disposed in the channel during use. In some embodiments, the pilothole forming trocar assembly includes two spikes and two positionretention members to form pilot holes and retain position to allowinserting a staple having a bridge and two arms into the formed pilotholes.

In a method for fixing a positioned sheet-like material to bone, aposition retention sleeve is provided having a lumen extendingtherethrough and at least one position retention member proximate adistal end of the position retention sleeve. A trocar sized for beingreleasably disposed within the lumen of the position retention sleeveand including at least one distally extending spike is also provided.

The trocar may be positioned within the position retention sleeve withthe at least one spike extending beyond the distal end of the positionretention sleeve. The spike may then be driven into the bone to form atleast one pilot hole. The trocar may then be removed with the positionretention member maintaining the sleeve position relative to the formedpilot hole or holes.

A staple delivery device is provided having a barrel sized fordisposition within the lumen of the position retention sleeve. Thebarrel can be keyed for controlled rotational position of the barrelrelative to the position retention sleeve. The staple delivery barrelmay then be inserted into the sleeve lumen and the staple deployed.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel FIG. 1 is a simplified perspective view of a pilot holeforming trocar assembly, including a trocar disposed within a positionretention sleeve for creating pilot holes and retaining the sleeverelative to the formed pilot holes for delivery of a tissue fastener orstaple;

FIG. 2 is a perspective view of the position retention sleeve of FIG. 1with the trocar removed;

FIG. 3 is a perspective view of the trocar of FIG. 1 as removed from theposition retention sleeve;

FIGS. 4A and 4B are partial cross sectional views of the distal portionof the trocar of FIG. 3 depicting pilot hole forming spikes and aretractable blade;

FIG. 5 is a perspective view of a position retention member which can bemounted in a distal portion of the position retention sleeve in oneembodiment of the present disclosure;

FIG. 6 is a simplified perspective view of a tissue fastener or stapledelivery device in accordance with the present disclosure;

FIG. 7 is a stylized perspective view illustrating an exemplaryprocedure for arthroscopic treatment of a shoulder of a patient inaccordance with one embodiment of the disclosure;

FIG. 8 is a stylized perspective view of a shoulder including asupraspinatus having a distal tendon with a sheet-like material affixedthereto;

FIG. 9A is simplified perspective view of a shoulder having an implantaffixed to the tendon and depicting the first step in a method ofdelivering fasteners to affix the implant to bone of the humeral head inaccordance with one method of the disclosure;

FIG. 9B is a simplified plan view of the distal portion of the trocarassembly as positioned to create pilot holes for affixing the implant tobone in a further step of a method of the disclosure;

FIG. 9C depicts the trocar assembly of FIG. 9B as inserted into the boneto form pilot holes in accordance with a method of the disclosure;

FIG. 9D depicts the trocar assembly with the trocar portion removed andthe remaining sheath assembly retaining its position in the pilot holesformed;

FIG. 9E depicts insertion of a fastener or staple into the formed pilotholes through the sheath assembly in accordance with a method of thedisclosure;

FIG. 9F illustrates a fastener or staple as inserted in accordance witha method of the disclosure; and,

FIGS. 10A-10D schematically illustrate alternative position retentionmembers.

DETAILED DESCRIPTION

The following detailed description should be read with reference to thedrawings in which similar elements in different drawings are numberedthe same. The drawings, which are not necessarily to scale, depictillustrative embodiments and are not intended to limit the scope of theinvention.

Apparatus and methods as described in this disclosure can be used toposition and deploy fasteners or staples to attach tissue and implantsto bone. In at least some applications, the staple is generally flexibleand include a pair of arms connected by a bridge with the arms havingtrunk portions thereon. Staples can include those disclosed inco-pending applications U.S. Provisional Application No. 61/577,626filed on Dec. 19, 2011, Attorney Docket No. 10322-712.100 entitled,“FASTENERS AND FASTENER DELIVERY DEVICES FOR AFFIXING SHEET-LIKEMATERIALS TO BONE OR TISSUE”; U.S. Provisional Application No.61/577,632 filed on Dec. 19, 2011, Attorney Docket No. 10322-713.100entitled, “FASTENERS AND FASTENER DELIVERY DEVICES FOR AFFIXINGSHEET-LIKE MATERIALS TO BONE OR TISSUE” and U.S. Provisional ApplicationNo. 61/577,635 filed on Dec. 19, 2011, Attorney Docket No. 10322-714.100entitled, “FASTENERS AND FASTENER DELIVERY DEVICES FOR AFFIXINGSHEET-LIKE MATERIALS TO BONE OR TISSUE,” the disclosures of which areincorporated herein by reference. The trunk portions can include areasof relative lateral weakness and can further include an increase inflexibility at the transition from the trunk to the non-trunk portion ofthe arm or the transition from the trunk to the bridge. These areas offlexibility can provide improved staple retention as these portionsallow flexing and bending in response to increasing pullout forces. Withthis flexibility, the fasteners cannot be pounded or driven into bone orother tissue as a conventional hard staple would be driven into paper,wood, tissue or bone. Therefore, for application of the staple of thepresent disclosure to affixing tissue or implants to bone, the staplesare generally included in a kit that also includes a staple deliverydevice 200 (generally illustrated in FIG. 6) and a pilot hole formingtrocar assembly 300, as schematically illustrated in FIGS. 1-5 anddescribed in detail below.

The pilot hole forming trocar assembly 300, illustrated generally inFIG. 1 includes a trocar 302 and a position retention sleeve 304. Thetrocar 302 is releasably coupled to the position retention sleeve 304and slides in keyed arrangement within the sleeve 304 when uncoupled.The trocar 302 includes a distal portion having a retractable blade 306and a pair of pilot hole forming spikes 308 extending distally from thetrocar shaft. The retractable blade 306 is useful in inserting theassembly through an incision. The retractable blade 306 can be retractedby activating release button 315 which causes a spring (not shown) topull the retractable blade 306 into the shaft of the trocar within theposition retention sleeve 304. In this position, the pilot hole formingspikes remain extended from the trocar. In some embodiments theretractable blade 306 can be omitted, such as when the pilot holeforming trocar assembly is to be inserted into an incision that alreadyhas a cannula extending therethrough to provide an instrument path.

Referring to FIGS. 2-5, details of the elements of one exemplaryembodiment of a pilot hole forming trocar assembly 300 are illustrated.The pilot hole forming trocar assembly 300 is used to create pilot holesin a bone for subsequent placement of a staple or fastener. Further, thepilot hole forming trocar assembly 300 includes a means for retaininginstrument position with respect to the pilot holes when the trocar isremoved so that a staple delivery device 200 (see FIG. 6) can beinserted and the staple be in alignment with the already formed pilotholes. This prevents the time and difficulty associated with finding thepilot holes with the staple, which in fact may not be possible for manypractitioners.

As previously stated, a pilot hole forming trocar assembly 300 caninclude a trocar 302 and a position retention sleeve 304. One embodimentof a position retention sleeve 304 is illustrated in FIG. 2. Theposition retention sleeve 304 includes a shaft 311 having a lumen 310extending therethrough. The lumen 310 is sized to receive the trocar 302when used to form pilot holes. The lumen 310 is also sized to receive astaple delivery device 200 when used to position a staple in pilot holesformed in bone. The lumen is shaped or keyed to cooperate with either ofthese instruments or other instruments so that relative rotationalposition of the trocar 302 or staple delivery device 200 is fixed whenslidably positioned in the position retention sleeve 304. An opening orwindow 313 may be included near the distal end of the position retentionsleeve to allow viewing of devices inserted therein.

Position retention members 314 extend distally from the shaft 311. Asdetailed in FIG. 5, the position retention members can be included on aninsert 312 that is affixed proximate the distal end of the shaft 311.Alternatively, the position retention members can be integral to theshaft 311. The position retention members are sized and designed toextend into pilot holes as they are formed by the trocar 302 describedbelow. When the trocar 302 is removed, the position retention members314, along with the sleeve 311 remain in position to provide a guide forthe staple delivery device 200 to be inserted into proper position andposition a staple in the pilot holes. As depicted, the positionretention members 314 can include longitudinally extendingsemi-cylindrical projections. In the disclosed embodiment, the pilothole forming spikes 308 of the trocar 302 slide within the partiallumens of the position retention members 314. This design can providesupport for the spikes as they are pounded into bone and can also allowthe position retention members to readily slide into pilot holes formedby the spikes 308.

A more detailed depiction of one alternative embodiment of a trocar 302is included in FIG. 3. The trocar includes a shaft 320 having at itsproximal end a knob 324 that can be used to pound or push the trocar 302into bone. The trocar can further include a collar 322 which can be usedto releasably engage the position retention sleeve 304 when the two aremated for forming pilot holes. A spring 323 can be included which causesor aids the retraction of the trocar when it is released from theposition retention sleeve.

As previously disclosed, the distal end of the trocar 302 includes twopilot hole forming spikes 308 extending from shaft 320. A retractableblade 306 is positioned between the spikes 308. In use, the blade 306 isretracted prior to the spikes 308 being used to form pilot holes inbone. FIGS. 4A and 4B are a partial cross sectional view of the distalportion of a trocar 302 illustrating the combination of pilot holeforming spikes 308 and a retractable blade 306. The retractable blade306 includes a proximally extending shaft 317 that is coupled to thepreviously discussed spring (not shown) and release button 315 whichoperates to pull the retractable blade into the lumen of the trocar 302.As illustrated, spikes 308 are fixed within lumens 309 in the trocar 302and extend distally therefrom, for example, the proximal end 307 ofspike 308 may be attached to the trocar 302. In FIG. 4A, the blade 306is shown in an extended position, while in FIG. 4B the blade has beenretracted. It is to be understood that spikes 308 are depicted asdistally tapering members that can be pounded into bone, however othershapes and configurations are possible within the scope of theinvention. For example, spikes 308 could be untapered or have a texturedsurface. Spikes 308 could also be in the form of rotating bits toeffectively drill the pilot holes in some embodiments.

Now referring to FIG. 6, a staple delivery device 200 is illustrated.The staple delivery device 200 can include a handle assembly 201 and abarrel assembly 205. The handle assembly 201 includes a trigger 203 thatis operatively coupled to mechanisms in the barrel assembly 205 todeploy a staple in pilot holes formed in bone. The staple deliverydevice 200 can be used in conjunction with the pilot hole forming trocarassembly 300 of FIG. 1.

The barrel assembly can include two main components, an outer sleeve 250having a lumen extending therethrough and a staple delivery assembly252. The outer sleeve 250 is secured to the handle assembly 201 in fixedrelationship when the staple delivery device 200 is assembled. Thestaple delivery assembly 252 is slidably disposed in the lumen and caninclude a proximal end extending beyond the proximal end of the outersleeve 250. The proximal end of the staple delivery assembly 252operatively interacts with trigger assembly 203 when the barrel 205 ismounted on the handle assembly 201. In the embodiment of FIG. 6, theouter surface of the sleeve 250 is shaped so as to be rotationally keyedand sized for desired fitting within the position retention sleeve 304.As illustrated, the sleeve 250 can include a flat surface 257 keyed tofit within a flat surface on the interior of the position retentionsleeve 304.

The staple delivery assembly 252 includes a fork 232 and two staplesetting rods. Staple setting rods 234 include a first staple setting rod234A and a second staple setting rod 234B. Both staple setting rods 234are affixed to a rod coupler near the proximal end of the stapledelivery assembly 252. When the barrel 205 is in an assembled state,first staple setting rod 234A and second staple setting rod 234B canextend through two grooves defined by the outer surface of the stapledelivery assembly 252. Each groove is dimensioned so that a staplesetting rod can be partially disposed therein while the sleeve 250surrounds the staple setting rods 234. When staple delivery device 200is in an assembled state, a staple may be carried by a first stake 238Aand a second stake 238B of fork 232.

Next referring to FIG. 7, an exemplary use or application of theapparatus of the present disclosure is described. FIG. 7 is a stylizedperspective view illustrating an exemplary procedure for treating ashoulder 22 of a patient 20. The procedure illustrated in FIG. 7 mayinclude, for example, fixing tendon repair implants to one or moretendons of shoulder 22. The tendons treated may be torn, partially torn,have internal micro-tears, be untorn, and/or be thinned due to age,injury or overuse.

Shoulder 22 of FIG. 7 has been inflated to create a cavity therein. Afluid supply 52 is pumping a continuous flow of saline into the cavity.This flow of saline exits the cavity via a fluid drain 54. A camera 56provides images from inside the cavity. The images provided by camera 56may be viewed on a display 58.

Camera 56 may be used to visually inspect the tendons of shoulder 22 fordamage. A tendon repair implant in accordance with this disclosure maybe affixed to a bursal surface of the tendon regardless of whether thereare visible signs of tendon damage. Applicants believe that the methodsand apparatus of the present application and related devices may providevery beneficial therapeutic effect on a patient experiencing joint painbelieved to be caused by internal microtears, but having no clear signsof tendon tears. By applying a tendon repair implant early before a fulltear or other injury develops, the implant may cause the tendon tothicken and/or at least partially repair itself, thereby avoiding moreextensive joint damage, pain, and the need for more extensive jointrepair surgery.

An implant delivery system 60 can be seen extending from shoulder 22 inFIG. 7. Implant delivery system 60 is extending through a first cannula80A. In certain embodiments, first cannula 80A can access a treatmentsite within shoulder 22 using a lateral approach in which first cannula80A pierces the outer surface of a right side of the patient's body. Insome cases a physician may choose not to use a cannula in conjunctionwith implant delivery system 60. When that is the case, the implantdelivery system may be advanced through tissue. Implant delivery system60 comprises a sheath that is affixed to a handle. The sheath defines alumen and a distal opening fluidly communicating with the lumen. In theembodiment of FIG. 7, the distal opening of the sheath has been placedin fluid communication with the cavity created in shoulder 22.

A tendon repair implant is at least partially disposed in the lumendefined by the sheath of implant delivery system 60. Implant deliverysystem 60 can be used to place the tendon repair implant inside shoulder22. In some embodiments, the tendon repair implant is folded into acompact configuration when inside the lumen of the sheath. When this isthe case, implant delivery system 60 may be used to unfold the tendonrepair implant into an expanded shape. Additionally, implant deliverysystem 60 can be used to hold the tendon repair implant against thetendon.

The tendon repair implant may be affixed to the tendon while it is heldagainst the tendon by implant delivery system 60. Various attachmentelements may be used to fix the tendon-repair implant to the tendon.Examples of attachment elements that may be suitable in someapplications include sutures, tissue anchors, bone anchors, and staples.In the exemplary embodiment of FIG. 7, the shaft of a fixation tool 70is shown extending into shoulder 22. In one exemplary embodiment,fixation tool 70 is capable of fixing the tendon repair implant to thetendon and bone with one or more staples of the present disclosure whilethe tendon repair implant may be held against the tendon by implantdelivery system 60.

For purposes of illustration, a shoulder 22 of patient 20 is shown incross-section in FIG. 8. Shoulder 22 includes a humerus 14 and a scapula12. In FIG. 8, a head 24 of humerus 14 can be seen mating with a glenoidfossa of scapula 12 at a glenohumeral joint. The glenoid fossa comprisesa shallow depression in scapula 12. The movement of humerus 14 relativeto scapula 12 is controlled by a number of muscles including: thedeltoid, the supraspinatus, the infraspinatus, the subscapularis, andthe teres minor. For purposes of illustration, only the supraspinatus 26is shown in FIG. 8.

With reference to FIG. 8, a distal tendon 28 of the supraspinatus 26meets humerus 14 at an insertion point. Scapula 12 of shoulder 22includes an acromium 32. A tendon repair implant 50 has been affixed toa surface of distal tendon 28. Tendon repair implant 50 may comprise,for example, various sheet-like structures without deviating from thespirit and scope of the present detailed description. In some usefulembodiments, the sheet-like structure may comprise a plurality offibers. The fibers may be interlinked with one another. When this is thecase, the sheet-like structure may comprise a plurality of aperturescomprising the interstitial spaces between fibers. Various processes maybe used to interlink the fibers with one another. Examples of processesthat may be suitable in some applications include weaving, knitting, andbraiding. In some embodiments, the sheet-like structure may comprise alaminate including multiple layers of film with each layer of filmdefining a plurality of micro-machined or formed holes. The sheet-likestructure of the tendon repair implant may also comprise a reconstitutedcollagen material having a porous structure. Additionally, thesheet-like structure of the tendon repair implant may also comprise aplurality of electro-spun nanofiber filaments forming a composite sheet.Additionally, the sheet-like structure may comprise a synthetic spongematerial that defines a plurality of pores. The sheet-like structure mayalso comprise a reticulated foam material. Reticulated foam materialsthat may be suitable in some applications are available from BiomerixCorporation of Fremont, Calif. which identifies these materials usingthe trademark BIOMATERIAL™. The sheet-like structure may be circular,oval, oblong, square, rectangular, or other shape configured to suit thetarget anatomy.

Various attachment elements may be used to fix tendon repair implant 50to distal tendon 28 without deviating from the spirit and scope of thisdetailed description. Examples of attachment elements that may besuitable in some applications include sutures, tissue anchors, boneanchors, and staples. In the embodiment of FIG. 8, sheet-like implant 50is affixed to distal tendon 28 by a plurality of tendon staples 51.Sheet-like implant 50 is affixed to humerus 14 by a plurality of bonestaples using an apparatus and method of the present disclosure.

In some exemplary methods, a plurality of staples may be applied using afixation tool. After the staples are applied, the fixation tool may bewithdrawn from the body of the patient. Distal tendon 28 meets humerus14 at an insertion point 30. With reference to FIG. 8, it will beappreciated that sheet-like implant 50 extends over insertion point 30.Tendon repair implant may be applied to distal tendon 28. In variousembodiments, staples may straddle the perimeter edge of the sheet-likeimplant (as shown in FIG. 8), may be applied adjacent to the perimeter,and/or be applied to a central region of the implant. In someembodiments, the staples may be used to attach the implant to softtissue and/or to bone.

The exemplary apparatus and methods described herein may be used toaffix tendon repair implants to various target tissues. The shoulderdepicted in FIG. 8 is one example where a tendon repair implant may beaffixed to one or more bones associated with an articulating joint, suchas the glenohumeral joint. Additionally, the tendon repair implant maybe affixed to one or more tendons to be treated. The tendons to betreated may be torn, partially torn, have internal micro-tears, beuntorn, and/or be thinned due to age, injury or overuse. Applicantsbelieve that the methods and apparatus of the present application andrelated devices may provide very beneficial therapeutic effect on apatient experiencing joint pain believed to be caused by partialthickness tears and/or internal microtears. By applying a tendon-repairimplant early before a full tear or other injury develops, the implantmay cause the tendon to thicken and/or at least partially repair itself,thereby avoiding more extensive joint damage, pain, and the need formore extensive joint repair surgery.

An exemplary method of the present disclosure for forming pilot holesand delivering staples to bone is described with respect to FIGS. 9A-9Fwhich depict the various steps in affixing an implant 50 to bone withstaples or fasteners. FIG. 9A schematically depicts a shoulder 22 of apatient 20 having an implant 50 positioned over a supraspinitus tendon28. The implant is partially affixed to the tendon 28 with fasteners 51and extends laterally to and over the insertion point of the tendon tothe humeral head 24. As depicted, the implant 50 is not yet affixed tothe humeral head 24. A distal portion of a pilot hole forming trocarassembly 300, in particular the position retention sleeve 304, isdisposed over a desired location near the lateral edge of the implant 50where it overlies the humeral head 24. It is noted that FIG. 9A is adepiction with all overlying tissue removed from the shoulder 22 toclearly show the location of the entire implant 50 on the supraspinitustendon 28. This view is typically not possible during actualarthroscopic procedures in which the fasteners and instruments of thepresent disclosure can be used, however the depiction provides a clearunderstanding of the placement of an implant and the use of fastenersdisclosed herein. In actual use the surgeon will typically have a sideview from a viewing scope (not shown) of a small space created byinflating the area with fluid and clearing necessary obstructions fromthe implant area.

FIG. 9B is a schematic illustration of a cross-sectional side view ofthe partially affixed implant of FIG. 9A showing the small portion ofthe implant 50 that is not yet affixed to the humeral head 24. As can beseen in the illustration, the humeral head 24 is shown in cross-sectionwhich illustrates the composite nature of bone structure. In general,bone includes hard outer portion or cortical layer 375 and a poroussofter inner portion or cancellous bone 376. The pilot hole formingtrocar assembly 300 is positioned with the spikes 308 over a selectedposition on the implant 50. As previously discussed, the trocar 302 ispositioned within the lumen of the position retention sleeve 304 withspikes 308 extending distally. The spikes 308 can be used to manipulateand position the implant as needed. Once in position, the spikes 308 canbe driven into the bone.

Referring to FIG. 9C, the illustration of FIG. 9B is re-illustrated withthe pilot hole forming trocar 300 spikes pounded or otherwise driveninto the humeral head 24, penetrating the cortical layer 375 into thecancellous portion 376. As illustrated, position retention members 314also penetrate the bone with the spikes 308. In FIG. 9D, it isillustrated that the trocar 302 and its distal spikes 308 are nowremoved leaving formed pilot holes 309 with the position retentionsleeve 304 remaining in position with position retention member 314extending into pilot holes 309. The position retention member 304 lumenprovides a guide to the pilot holes 309 for a staple delivery device200. In FIG. 9E, a staple 100 is shown extending into the pilot holes309 as mounted on the distal end of a staple delivery device 200 thathas been inserted into the lumen of position retention member 304. Inthis position the staple can be delivered and retained in the bone aspreviously described in the various embodiments disclosed herein. FIG.9F depicts a staple 100 as delivered into bone with bridge 304 holdingthe implant in position on the bone and arms of the staple retainingposition in the bone, such as within the cancellous portion 376.

As previously discussed, the position retention members of FIG. 2 caninclude semi-cylindrical projections that fit within the pilot holeswhen formed by the spikes. However, alternative embodiments of positionretention members are possible with some exemplary elements depicted inFIGS. 10A-10D. Each of these Figures illustrate a distal portion of aposition retention sleeve 304. As seen in these exemplary views, thedistal end includes a slot or other shaped opening 380 which allows thepassage of a distal portion of either a staple delivery device 200 orthe spikes 308 of a trocar 302. In FIG. 10A, the position retentionmembers are spikes 381 which are pounded into bone to retain thesleeve's position, but the spikes do not extend into the pilot holes forthe staple. FIG. 10B depicts rounded blades 383 that may cut into thebone surface to retain position. Alternatively, FIG. 10C illustrates aseries of spikes 385 that may interact with the bone surface to retainposition relative to pilot holes when formed. Finally, FIG. 10Dillustrates a barbed projection 387 that can be used to retain theposition of the instrument with respect to pilot holes formed in bone.

While exemplary embodiments of the present invention have been shown anddescribed, modifications may be made, and it is therefore intended inthe appended claims and subsequently filed claims to cover all suchchanges and modifications which fall within the true spirit and scope ofthe invention.

What is claimed is:
 1. A pilot hole forming trocar assembly comprising:a position retention sleeve having a lumen extending therethrough and atleast one position retention member proximate a distal end of theposition retention sleeve, the position retention member beingconfigured to engage bone; and, a trocar sized for being releasablydisposed within the lumen of the position retention sleeve including atleast one distally extending spike, wherein when assembled for use theat least one distally extending spike extends beyond the distal end ofthe position retention sleeve to form a pilot hole when contacted withbone.
 2. The pilot hole forming trocar assembly of claim 1, furthercomprising a collar for releasably coupling the trocar to the positionretention sleeve.
 3. The pilot hole forming trocar assembly of claim 1,wherein the trocar further comprises a proximal knob portion having asurfacing for pounding the at least one spike into bone.
 4. The pilothole forming trocar assembly of claim 1, wherein the trocar furthercomprises a retractable blade disposed at a distal end thereof.
 5. Thepilot hole forming trocar assembly of claim 1 wherein the at least oneposition retention member comprises a semi-cylindrical member defining alongitudinal channel over the length thereof that is sized to allow theat least one spike of the trocar to be disposed in the channel duringuse.
 6. The pilot hole forming trocar assembly of claim 5, wherein twospikes and two position retention members are included to form pilotholes and retain position to allow inserting a staple having a bridgeand two arms into formed pilot holes.
 7. The pilot hole forming trocarassembly of claim 1, wherein the position retention member is a barbedprojection.
 8. The pilot hole forming trocar assembly of claim 1,wherein the at least one spike has a distally tapering cross section. 9.The pilot hole forming trocar assembly of claim 1, further comprising aviewing window proximate a distal end of the position retention member.10. A kit for deploying a staple in bone for fixing a sheet-like implantin position on a tendon, the kit comprising: a position retention sleevehaving a lumen extending therethrough and at least one positionretention member proximate a distal end of the position retentionsleeve; a trocar sized for being releasably disposed within the lumen ofthe position retention sleeve, the trocar including at least onedistally extending spike, wherein when assembled for use the at leastone distally extending spike extends beyond the distal end of theposition retention sleeve to form a pilot hole when contacted with bone;and, a staple delivery device having a barrel sized for dispositionwithin the lumen of the position retention sleeve and delivery of astaple from a distal portion thereof, wherein the barrel is keyed forcontrolled rotational position of the barrel relative to the positionretention sleeve.
 11. The kit of claim 10, further comprising a collarfor releasably coupling the trocar to the position retention sleeve. 12.The kit of claim 10, wherein the trocar further comprises a proximalknob portion having a surfacing for pounding the at least one spike intobone.
 13. The kit of claim 10, wherein the trocar further comprises aretractable blade disposed at a distal end thereof.
 14. The kit of claim10 wherein the at least one position retention member comprises asemi-cylindrical member defining a longitudinal channel over the lengththereof that is sized to allow the at least one spike of the trocar tobe disposed in the channel during use.
 15. The kit of claim 14, whereintwo spikes and two position retention members are included to form pilotholes and retain position to allow inserting a staple having a bridgeand two arms into formed pilot holes.
 16. The kit of claim 10, whereinthe position retention member is a barbed projection.
 17. The kit ofclaim 10, wherein the at least one spike has a distally tapering crosssection.
 18. The kit of claim 10, further comprising a viewing windowproximate a distal end of the position retention member.
 19. A methodfor fixing a positioned sheet-like material to bone comprising the stepsof: providing a position retention sleeve having a lumen extendingtherethrough and at least one position retention member proximate adistal end of the position retention sleeve; providing a trocar sizedfor being releasably disposed within the lumen of the position retentionsleeve, the trocar including at least one distally extending spike;positioning the trocar within the position retention sleeve with the atleast one spike extending beyond the distal end of the positionretention sleeve; driving the spike into bone to form at least one pilothole; removing the trocar with the position retention member maintainingthe sleeve position relative to the at least one formed pilot hole;providing a staple delivery device having a barrel sized for dispositionwithin the lumen of the position retention sleeve wherein the barrel iskeyed for controlled rotational position of the barrel relative to theposition retention sleeve; and, inserting the staple delivery barrelinto the sleeve lumen and deploying a staple.
 20. The method of claim19, further comprising using the distal end of the at least one spike toreposition at least a portion of the sheet-like material.